Associate Director, Clinical Research

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Clinical Development & Research – Non-MD

Job Category:

Scientific/Technology

All Job Posting Locations:

Irvine, California, United States of America

Job Description:

Johnson & Johnson MedTech, Neurovascular, is recruiting an Associate Director, Clinical Research, to join our team.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com/. 

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

Hong Kong- Requisition Number: R-092029

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Neurovascular? Ready to join a team that’s reimagining how we heal? Our Neurovascular team develops leading solutions for hemorrhagic and acute ischemic stroke. You will join a proud heritage of continually elevating standards of care for neurovascular stroke patients.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech. 

JOB SUMMARY

This Associate Director, Clinical Research will be leading a team of clinical research professionals to manage clinical trials and to deliver evidence generation/dissemination strategies (EGS/ EDS) for multiple and/or complex projects within the JJMT Neurovascular Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.

DUTIES & RESPONSIBILITIES*

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Is responsible for the execution of Clinical R&D activities for multiple and/ or complex projects.
• Manages team of clinical research professionals to manage clinical trials;
• Is responsible for clinical team’s interface and collaboration with key opinion leaders, investigators, IRBs/ECs, Regulatory agencies, contractors/vendors, societies, associations, and company personnel;
• Provides inputs on the development and executes the delivery of appropriate Global Evidence Generation Strategies (EGS)/ Evidence Dissemination Strategies (EDS) to support New Product Development and Life-Cycle Management for transformational/ complex programs,
• Foster collaborative relationships with all relevant Clinical R&D partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access, R&D, etc), ensuring cross-functional alignment;
• Coordinates input and alignment from key regional MD Clinical R&D leads and other countries/ regions in the development of the EGS/ EDS;
• Leads study design to develop appropriate clinical trials to meet the clinical evidence needs;
• Fosters strong working relationships with external stakeholders;
• Partners with internal stakeholders to ensure accurate dissemination of clinical data/evidence in value briefs and technical summaries for market access and reimbursement;
• Is responsible for delivery of assigned clinical programs, through effective partnership with internal/external stakeholders, to enable optimized engagement leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs);
• Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders;
• Monitors assigned project budgets to ensure adherence to globally defined business plans; 
• Leads clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc, including during sponsor regulatory inspections, in line with global frameworks;
• Serves as the clinical representative on a New Product Development team;
• Is responsible for development of Post-Market Clinical Follow-up (PMCF) Plans and Reports, in line with global frameworks;
• Conducts review of promotional materials to ensure fair-balance, accuracy in clinical claims and messaging;
• Manages and mentors resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency;
• Is responsible for providing performance feedback to direct reports (if applicable) as well as coaching and assistance in their development;
• Responsible for communicating business related issues or opportunities to next management level;
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable;
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable;
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures;
• Performs other duties assigned as needed;

EXPERIENCE AND EDUCATION*

Education

• Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.

Experience

• A minimum of 8 years related scientific/ technical experience, including leadership/ management role within Clinical Research.
• Significant previous experience in clinical project leadership across multiple studies/ programs is required.
• Experience working well with cross-functional teams is required.
• Experience with budget planning, tracking and control is required.
• Relevant industry certifications is preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR,…).
• Clinical/medical background is a plus.
• A minimum of 1-2 year people management related experience is a plus.
• Medical device experience is highly preferred.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*

Functional and Technical Competencies:

• Deep expertise in clinical research science and processes along with a broad and extensive understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations;
• Ability to lead cross-functional teams to provide scientific clinical research input across New Product Development (NPD) and Life-Cycle Management (LCM) projects, including complex and/ or transformational projects;
• Proven track record in delivering clinical programs within clinical/ surgical research setting, on time, within budget and in compliance to SOPs and regulations;
• Strong presentation and technical writing skills;
• Strong written and oral English communication skills;
• Comprehensive understanding of clinical trial regulations across multiple regions;
• Ability to collaborate across different functional areas within Clinical R&D to ensure alignment with governance processes and to meet business objectives;
• Through transparent leadership, support shaping a high-performing team with a global culture;
• Demonstrates competencies in the following area are required:
  • Ability to lead teams to deliver critical milestones, including complex projects
  • Advanced technical writing skills
  • Strong project management skills with ability to handle multiple projects
  • Strong people management skills
  • Effective management of project budget processes
  • Ability to influence, shape and lead without direct reporting authority
  • Change agent in team development and progression

Leadership Competencies:

Strong leadership required in alignment with J&J Leadership Imperatives:

• Connect – Foster strong partnership with key internal and external stakeholders to ensure development and timely delivery of innovative EGS/ EDS.
• Shape – Build strong working relationships with external stakeholders and through efficient use of resources, positively influence and shape the way clinical trial management is conducted and resources are utilized.
• Lead – Continue to develop expertise to be able to provide inputs in the development of scientific clinical research strategies for complex programs, in line with global strategies. Through transparent leadership, ensure appropriate escalation of compliance issues.
• Deliver - Ensure clinical programs are delivered on time, within budget and in compliance to SOPs and regulations. Ensure all sponsored studies have appropriately trained clinical trial leaders/ specialists assigned.

LOCATION & TRAVEL REQUIREMENTS

• Primary location for this position is per management discretion.  The position may be performed remotely.
• Ability to travel approximately 20-25% depending on the phase of the program

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. 

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Clinical Evaluations, Corrective and Preventive Action (CAPA), Drug Discovery Development, Entrepreneurship, Good Clinical Practice (GCP), Leadership, Medicines and Device Development and Regulation, Presentation Design, Regulatory Affairs Management, Relationship Building, Research Documents, Safety-Oriented, Scientific Research, Strategic Change, Study Management, Tactical Planning, Technical Credibility

The anticipated base pay range for this position is :

$137,000.00 - $235,750.00

Additional Description for Pay Transparency:

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits